Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0533

2. Registrant Information.

Registrant Reference Number: 2017KP041

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-142

Product Name: k9 advantix II medium dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On an unknown date in Aug 2015, a 16 year old, male, Pinscher (Miniature) canine, of an unknown weight and reproductive status, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. The product was continued monthly.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Seizure

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On an unknown date in Aug 2015, the dog had intermittent seizures. It is unknown if the dog had been examined or treated by a veterinarian. On an unknown date in Feb 2016, the dog was administered 1 tube of K9 Advantix II Medium Dog topically by the owner. On an unknown date in Feb 2016, the dog died. No necropsy was performed. No further information expected. This case is closed. The intent of the call was to discuss product use on another pet and not to report the death of the dog.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke intermittent seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Moreover, dog tolerated previous applications well, without neurological signs. Seizures reported by owner and no vet consulted. Thus possibly misinterpretation of sign. Later reported death after further product application is not expected either, as inconsistent with pharmaco-toxicological product profile. Very long time for reporting as the intent of the call was to discuss product use on another pet and not to report the death of the dog. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other etiologies more probable in this geriatric dog. Considering overall aspects, a product connection deemed to be unlikely.